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Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01359995
First Posted: May 25, 2011
Last Update Posted: May 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.

Condition
Cytomegalovirus Endotheliitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • clinical courses before and after topical ganciclovir in patients with CMV endotheliitis [ Time Frame: participants will be monitored after receiving topical ganciclovir,an expected average of 1 year ]
    evaluations including aqueous PCR for CMV, endothelium cell density on confocal microscopy,degree of anterior chamber inflammation..


Estimated Enrollment: 7
Study Start Date: November 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Detailed Description:

In this study, we recruit 7 immunocompetent patients with unexplained graft failures, which mimicked herpetic anterior uveitis and graft rejection initially, were diagnosed as CMV endotheliitis after aqueous tapping for CMV polymerase chain reaction (PCR). Topical ganciclovir was used to control and prevent the reactivation of CMV without systemic application and their clinical courses were presented after this treatment modality.

The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
4 men, 3 women, aged 40-90 years old
Criteria

Inclusion Criteria:

  • immunocompetent patients with positive results of the CMV PCR (polymerase chain reaction) from aqueous humor tapping receiving penetrating keratoplasty

Exclusion Criteria:

  • patients receiving systemic or intravitreal ganciclovir before topical ganciclovir use
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359995


Contacts
Contact: I-Jong Wang, M.D. PhD 886-23123456 ext 65729 ijong@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: I-Jong Wang, M.D. PhD    886-23123456 ext 65729    ijong@ms8.hinet.net   
Principal Investigator: I-Jong Wang, M.D. PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: I-Jong Wang, M.D. PhD National Taiwan University Hospital
  More Information

Publications:
Responsible Party: I-Jong Wang, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01359995     History of Changes
Other Study ID Numbers: 201010033R
First Submitted: May 16, 2011
First Posted: May 25, 2011
Last Update Posted: May 25, 2011
Last Verified: May 2011

Keywords provided by National Taiwan University Hospital:
cytomegalovirus endotheliitis

Additional relevant MeSH terms:
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action